Intranasal Fentanyl for Pain Management

NCT ID: NCT00882960

Last Updated: 2011-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-04-30

Brief Summary

Goal of the research will be to demonstrate a reduction in reported pain following the atomization and intra-nasal administration of Fentanyl versus the reduction in pain achieved from intravenous Fentanyl. It is hypothesized that pain should be reduced following fentanyl administration using the intra-nasal atomization equal to the intravenous delivery.

Detailed Description

Currently, pre-hospital providers have the ability to administer analgesia to patients through only intravenous routes. Often times patients have been exposed to the elements, present with poor anatomy, or are in such a position that makes establishing intravenous impractical or impossible. The lack of delivery method than prevents the patients from receiving humane and indicated pain medication. In patients who access is achieved, they are first subjected to a painful procedure that often will be repeated within twenty-four hours by most hospital policies and than subjects them to potential infection risk, being often times in less than aseptic conditions.

The goal of the study will be to test the method of administration of pain medication using atomization through an intra-nasal route as compared to the current standard of drug administration intravenous. The medication to be administered will be Fentanyl, a previously established and approved pre-hospital analgesic medication. As with any drug there are potential risks associated with unknown side effects or allergies, the risk would not be enhanced given the use of a different delivery device. Specific risks associated with the use of this delivery route would include but not be limited to potential soft tissue injuries, epistaxis, and aspiration

The study will measure reduction in pain following the delivery of atomized fentanyl via intra-nasal administration as compared with intravenous. We will ask participants to quantify their pain using the Wong-Baker FACES pain scale (previously established valid instrument of pain assessment) and assign a number to the pain they are feeling. The drug will than be administered using the atomizer and two subsequent reports of pain using the same scale will be taken along with vital signs.

Conditions

Trauma; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

patients who are randomized to receive intravenous fentanyl for control of their pain

Group Type: ACTIVE_COMPARATOR

intravenous fentanyl

Intervention Type: DRUG

An IV will be established and used to deliver Fentanyl at 50 micrograms to patients who meet pre-hospital protocol for pain management. Examples of this may be burn patients, fractures, trauma.

2

patients who are randomized to receive intra-nasal fentanyl for control of their pain

Group Type: ACTIVE_COMPARATOR

intra-nasal fentanyl

Intervention Type: DRUG

a mucosal atomization device will be used to deliver 50 mcg of Fentanyl to patients who have been identified at requiring pre-hospital pain management

Interventions

intravenous fentanyl

An IV will be established and used to deliver Fentanyl at 50 micrograms to patients who meet pre-hospital protocol for pain management. Examples of this may be burn patients, fractures, trauma.

Intervention Type: DRUG

intra-nasal fentanyl

a mucosal atomization device will be used to deliver 50 mcg of Fentanyl to patients who have been identified at requiring pre-hospital pain management

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Persons who meet the current State of Michigan County of Oakland and County of Genesee pre-hospital pain requiring analgesia.
• Examples of these patients would be those with fractures, kidney stones, or traumatic injuries, burns.

Exclusion Criteria

• Patients who have compromised nasal pharynx such as those who have obvious fractures or epistaxis.
• Additionally patients who are in the supine position for cervical spine immobilization will be excluded.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genesys

OTHER

Sponsor Role: lead

Responsible Party

Genesys Regional Medical Center

Principal Investigators

Alan R Janssen, D.O.

Role: STUDY_CHAIR

Director of Emergency Medicine Residency, Genesys Regional Medical Center

Ryan P Kirby, M.D.

Role: PRINCIPAL_INVESTIGATOR

Resident physician, Genesys Regional Medical Center

Stuart Etengoff, D.O.

Role: STUDY_DIRECTOR

Core Faculty, Department of Emergency Medicine, Genesys Regional Medical Center

Locations

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ryan P Kirby, M.D.

Role: CONTACT

ryan.kirby@genesys.org

810-606-5933

Facility Contacts

Ryan Kirby, M.D.

Role: primary

ryan.kirby@genesys.org

810-606-5933

Other Identifiers

104904-1

Identifier Type: -

Identifier Source: org_study_id